GEMINI STANDARD AND MINI VALVES by NEUROCARE GROUP

The Gemini Standard and Mini Valves are utilized in the treatment of hydrocephalic patients. They are components in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneal cavity.

This device should only be used by a physician or qualified personnel under the direction of a physician.

Care must be taken to ensure compliance with the manufacturer's instructions for use.

Prescription Use Only (Per 21 CFR 801.109)

Device Description

The Gemini Standard and Mini Valves are contoured silicone elastomer valves substantially equivalent to legally marketed predicate devices used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valves incorporate an internal low, medium or high pressure valve assembly which is mounted distal to an integral pumping reservoir for proximal control of CSF flow. The devices also prevent retrograde flow. Integral occluders are incorporated on the proximal and distal ends of the valves. The occluders are designed to manually control the flushing or pumping of CSF proximally or distally. The devices are fitted with a polypropylene needle guard, designed to prevent needle puncture through the valve base during percutaneous injection. The devices contain an integral plastic connector on each end to simplify the attachment of the catheters during the clinical procedure. The devices do not contain any ferrous metal parts which would interfere with magnetic resonance imaging or computerized axial tomography.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Gemini Standard and Mini Valves, which are medical devices used for treating hydrocephalus. This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a study with acceptance criteria and a detailed analysis of device performance against those criteria as would be typical for clinical studies evaluating new, non-substantially equivalent devices.

Therefore, the requested information cannot be fully provided from the given text. Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not present in the document. The 510(k) submission model relies on comparing the new device to a predicate device, arguing that its functionality, design, placement, and use are substantially equivalent, rather than setting and meeting specific performance acceptance criteria through clinical trials for a novel device.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not present as there is no "test set" in the context of a clinical performance study described. The basis for the 510(k) is a comparison to predicate devices, not performance on a specific dataset.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not present. Ground truth establishment is relevant for performance studies, which are not detailed in this 510(k) submission.

4. Adjudication Method:

This information is not present. Adjudication methods are used in clinical trials to resolve discrepancies in expert opinions for ground truth, which is not applicable here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not present. An MRMC study is a type of clinical trial that compares the performance of human readers with and without AI assistance. This document describes a medical device, not an AI algorithm, and does not include a comparative effectiveness study.

6. Standalone (Algorithm Only) Performance Study:

This information is not present. This is a medical device, not an algorithm, so a "standalone" algorithm performance study is not applicable.

7. Type of Ground Truth Used:

This information is not present. As no performance study is described, there's no mention of ground truth types (e.g., expert consensus, pathology, outcomes data).

8. Sample Size for the Training Set:

This information is not present. Training sets are relevant for machine learning algorithms, which are not the subject of this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established:

This information is not present. Similar to point 8, this is not applicable to the device described in the document.

Summary of What Is Provided (Context for the 510(k)):

Device Name: Gemini Standard and Mini Valves
Intended Use: Treatment of hydrocephalic patients by shunting cerebrospinal fluid (CSF) from the lateral ventricles of the brain to the right atrium of the heart or the peritoneal cavity.
Classification: Class II
Predicate Devices: Heyer-Schulte NeuroCare Low-Profile Valves (LPV, Mini-LPV, ProfileVS) K802586A, and Heyer-Schulte NeuroCare NOVUS Standard and Mini Valves K961859.
Basis for Equivalence: Substantially equivalent to predicate devices with respect to functionality, design, placement, and use in the neurosurgical arena.
Device Features: Contoured silicone elastomer valves, internal low/medium/high pressure valve assembly, integral pumping reservoir, prevents retrograde flow, integral occluders (proximal and distal), polypropylene needle guard, integral plastic connectors, no ferrous metal parts (MRI/CAT compatible).
Regulatory Mechanism: 510(k) premarket notification, demonstrating substantial equivalence.

In essence, the document serves as a regulatory submission and approval, stating that the new device is "substantially equivalent" to existing, legally marketed devices, rather than providing data from a clinical study on its performance against specific acceptance criteria.

Summary

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MAR | 0 1998

/C974708

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NeuroCare Group™
CAMINO® HEYER-SCHULTE®
NEURO NAVIGATIONAL® REDMOND™

December 16, 1997 Date:

Lori Hays Contact:

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is:

Name:

Gemini Standard and Mini Valves

Shunt. Central Nervous System and Components Classification Name:

The Gemini valves are substantially equivalent to other CSF shunting valves currently marketed known as the Heyer-Schulte NeuroCare Low-Profile Valves (LPV, Mini-LPV and ProfileVS). K802586A. and the Heyer-Schulte NeuroCare NOVUS Standard and Mini Valves, K961859, with respect to the functionality, design, placement and use in the neurosurgical arena.

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Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1, 0 1998

Ms. Lori Hays, MT (ASCP) ·Regulatory Submissions Specialist Heyer-Schulte NeuroCare, L.P. 8401 102nd Street, Suite 200 P.O. Box 390 Pleasant Prairie, Wisconsin 53158-0390

Re: K974708 Trade Name: Gemini Stantard and Mini Valves Regulatory Class: II Product Code: JXG Dated: December 16, 1997 Received: December 17, 1997

Dear Ms. Hays:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Ms. Hays

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 8 - DEVICE INDICATIONS FOR USE

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Gemini Standard and Mini Valves

Indications for Use: The Gemini Standard and Mini Valves are utilized in the treatment of hydrocephalic patients. They are components in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneal cavity.

This device should only be used by a physician or qualified personnel under the direction of a physician.

Care must be taken to ensure compliance with the manufacturer's instructions for use.

Prescription Use Only (Per 21 CFR 801.109)

Prescription Use
(Per 21 CFR 801.109)

bcoelefo

(Division Sign-Off)
Division of General Restorative Devices 1974700
510(k) Number

Regulation Number and Section

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).